CTC in Predicting Neoadjuvant Chemotherapy Among LABC Patients: a Single-center, Prospective, Exploratory Clinical Trial (CTCNeoBC)

April 23, 2022 updated by: Jinsong Lu, RenJi Hospital

Predictive Value of Circulating Tumor Cells in Neoadjuvant Chemotherapy Among Locally Advanced Breast Cancer Patients: a Single-center, Prospective, Exploratory Clinical Trial

The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. The purpose of this clinical trial is to evaluate the predictive value of CTC in neoadjuvant chemotherapy among locally advanced breast cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with histologically confirmed primary invasive breast adenocarcinoma, anatomic stage T2-4N0-3M0 or T1N1-3M0 before neoadjuvant chemotherapy
  • ECOG 0-1
  • Adequate organ function
  • Consent to undergo CTC analysis in vivo

Exclusion Criteria:

  • Pregnant or breastfeeding patients
  • Metastatic or recurrent patients
  • Uncontrollable infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GILUPI CellCollector®
Device: GILUPI CellCollector®
Use of GILUPI CellCollector® to detect CTC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Predictive value of CTC in ypT0 ypN0
Time Frame: Change from pre-chemotherapy to 22-28(±7) days after first dose of neoadjuvant chemotherapy
Change from pre-chemotherapy to 22-28(±7) days after first dose of neoadjuvant chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive value of CTC in ypT0, ypT0/is ypN0, near pCR
Time Frame: before and 22-28(±7) days after first dose of neoadjuvant chemotherapy
before and 22-28(±7) days after first dose of neoadjuvant chemotherapy
hypersensitivity
Time Frame: up to 1 year
Number of participants with hypersensitivity as assessed by CTCAE v4.0
up to 1 year
Detection rate of GILUPI CellCollector®
Time Frame: before and 22-28(±7) days after first dose of neoadjuvant chemotherapy
before and 22-28(±7) days after first dose of neoadjuvant chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Beijing Viroad Biotechnology Co., Ltd.

Investigators

  • Principal Investigator: Jinsong Lu, RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2018

Primary Completion (Actual)

March 11, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

October 8, 2018

First Submitted That Met QC Criteria

November 4, 2018

First Posted (Actual)

November 6, 2018

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 23, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RenJiH-2018-038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Locally Advanced Breast Cancer

Clinical Trials on GILUPI CellCollector®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe